Field of the Disclosure
The present disclosure relates generally to pharmaceutical compositions, and more particularly, to natural solubilizers and penetration enhancers that improve drug's permeability to the skin employed in transdermal pharmaceutical compositions for the delivery of active pharmaceutical ingredients (APIs).
Background Information
The delivery of active pharmaceutical ingredients (APIs) through a biological surface (e.g., skin tissue) is a well-recognized method of treatment for controlled drug delivery. Such APIs are delivered to the surface of the skin of a patient with transdermal delivery through the skin occurring thereafter.
Transdermal drug delivery is receiving increased attention because of the ability of an administration regime to provide a controlled route for the release of an API into the systemic circulation of the patient. The delivery of drugs using a transdermal methodology provides many benefits as compared to other delivery methods, such as, for example topical, oral, injection, and the like. Primarily, transdermal delivery is a comfortable, convenient and non-invasive way of administering drugs. Issues with other drug delivery methods include, for example, the variable rates of absorption of APIs in each metabolism encountered when using oral treatments, and other inherent inconveniences, such as, gastrointestinal irritation.
Transdermal delivery is a particularly advantageous delivery route. It is a non-invasive drug delivery method with the benefits of better patient compliance, less risk of infection, and lower cost than invasive procedures such as injection and implantation. Transdermal delivery also provides a much shorter onset time (e.g., the time from administration to therapeutic effect) than oral delivery does. Transdermal applications of APIs are simple and can be administered by a caregiver or the patient with minimal discomfort.
The lower solubility and relatively lower permeability of many APIs with diverse physicochemical characteristics can be improved using chemical enhancement means. Issues with most known chemical solubilizers and penetration enhancers include, for example, that they are often toxic, irritating, or allergenic. Improving APIs solubility may result in the decrease or elimination of penetration enhancers and thereby result in APIs becoming more bioavailable, and hence, more effective for a given dose. Accordingly, there is a need to provide improved API solubility, and improved skin permeation for use in transdermal pharmaceutical compositions.